FDA Drug Application (204940) for OMEGA-3-ACID ETHYL ESTERS by AMNEAL PHARMS

Back to FDA Applications sponsored by AMNEAL PHARMS

Application Number204940
Product Number001
FormCAPSULE;ORAL
Dosage1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AB Products meeting necessary bioequivalence requirements
Reference Drug
Drug NameOMEGA-3-ACID ETHYL ESTERS
Active IngredientOMEGA-3-ACID ETHYL ESTERS

Active IngredientCount
List of drugs with Active Ingredient OMEGA-3-ACID ETHYL ESTERS2


Back to FDA Applications sponsored by AMNEAL PHARMS